{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Andover",
      "address_1": "6 Tech Dr",
      "reason_for_recall": "The invasive pressure visual and audible alarms may not activate.",
      "address_2": "",
      "product_quantity": "28317 total products",
      "code_info": "Catalog Number(s): MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751",
      "center_classification_date": "20180416",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide)  and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil,  Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Liechtenstein, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Monaco, Mozambique, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Turkmenistan, United Kingdom, Utd.Arab.Emir. and Vietnam.",
      "state": "MA",
      "product_description": "Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751    Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.",
      "report_date": "20180425",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Draegar Medical Systems, Inc.",
      "recall_number": "Z-1382-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79648",
      "termination_date": "20200420",
      "more_code_info": "",
      "recall_initiation_date": "20180221",
      "postal_code": "01810-2434",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}